depigoid birch 5000 longterm study in adults and adolescents

Conditions: Allergic Rhinitis/Rhinoconjunctivitis +-Intermittent Asthma; Sensitization Against Betula Alba (Birch) Pollen

Summary: specific immunotherapy for ige mediated sensitization to birch pollen. long-term study to assess safety and efficacy of depigoid(r)birch 5000 - a modified pollen extract of betula alba (birch) - versus placebo.

investigation of the long-term efficacy and safety of depigoid birch 5000 according to the perennial treatment regimen in comparison to placebo in adult and adolescent patients with birch pollen-induced allergic rhinitis and/or rhinoconjunctivitis to show superiority vs. placebo. as the study includes adolescent patients it is run under an approved pip. total study duration per patient will be 5 years: 3 years of perennial treatment (application of study medication at intervals of 4-6 weeks) followed by a treatment-free observational phase of 2 years (seasons).

Eligibility criteria:
inclusion criteria: * availability of an appropriately signed and dated informed consent before any study specific examination, * clinical history of at least 2 years of seasonal allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma due to birch pollen allergy that has required repeated use of symptomatic treatment, * patients must have a minimum level of perception of symptoms from previous seasons defined as at least a moderate symptom level (i.e. a score of 2 on the 4-point-likert scale) in at least 2 symptom categories prior to randomization, * lung function ≥ 80% of the predicted normal value, * ige-mediated sensitization has to be verified by: * suggestive medical history, and * specific ige reactivity to birch pollen (cap-rast ≥ 2), and * a positive spt to birch pollen at screening or within 1 months prior to the screening visit. an spt is considered positive if it results in a wheal diameter of at least 3.0 mm * internet access so that patients can complete the ediary daily via internet during all 5 pollen seasons covered by the study protocol. exclusion criteria: * history of significant clinical manifestations of allergy as a result of sensitization against co-allergies, particularly-but not limited to-grass or weed pollen and perennial allergens (e.g. house dust mites, cat or dog). * history of anaphylactic reaction. * moderate or severe persistent asthma (gina 3 or 4). * mild persistent asthma (gina 2), according to the global initiative for asthma guidelines, necessitating treatment with inhaled glucocorticoids at a daily dose level of \> 400 µg budesonide dose equivalents. * lung function \< 80% of the predicted normal value (for pef: highest result of 3 measurements). * acute or chronic inflammatory or infectious airway diseases including recurrent acute or chronic sinusitis. * chronic structural diseases of the affected organs (e.g. eye, nose, lung). * history or presence of confirmed or potential diseases of the immune system including autoimmune diseases and immune deficiencies of actual clinical relevance. * any disease that prohibits the use of adrenaline (e.g. hyperthyroidism). * atopic dermatitis with scorad \>30 in the past or at screening. * ongoing or past full courses of sit against birch pollen within the last 5 years. * topical and systemic treatment with β-blockers. * concomitant treatment with substances interfering with the immune system beginning 1 week prior to start of treatment. * use of systemic corticosteroids within 3 months prior to visit 1-1. * immunization with vaccines within 7 days prior to visit 1-1. * treatment with antihistamines for any reason other than allergic symptoms due to birch pollen allergy. * changed residence between geographical regions since the last birch pollen season or not staying in the geographical region during the pre-determined birch pollen season. * nursing (lactating) women or women with a positive pregnancy test at the screening visit. women of childbearing potential must be using highly effective contraception during participation in this clinical study. a highly effective method of birth control is defined as one that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some iuds, sexual abstinence, or vasectomised partner.

Keywords: allergic rhinitis allergic rhinoconjunctivitis allergy induced asthma birch (betula alba) hayfever immunotherapy